MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number PED-400-18

Device Problems Break (1069); Positioning Failure (1158); Retraction Problem (1536)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/17/2021

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a pipeline that the pipeline was difficult to open and the pushwire was noted to be separated at the proximal marker after resistance occurred in the phenom catheter during retrieval.The patient was undergoing a procedure for flow diverter implantation to treat an unruptured saccular posterior communicating artery aneurysm.The aneurysm max diameter was 4mm and the neck diameter was 4mm.Vessel tortuosity was normal.It was reported that the pipeline and all accessory device were prepared as indicated in the instructions for use (ifu).The phenom catheter was in place and the pipeline was delivered.The tail end of the stent was difficult to open but after repeated attempts, it did finally open.The phenom was pushed forward and the wire was recovered but the proximal marker was stuck at the phenom tip.After pulling back, the pushwire was disconnected at the proximal marker and the distal part of the proximal marker remained in the patient's body.Attempts were made to collect the marker with a solitaire ab (sab) without success so the sab was deployed to prevent migration of the detached marker and the procedure was complete.There were no associated patient symptoms.

Manufacturer Narrative

H3: a pipeline flex embolization device and a phenom-27 catheter were returned for analysis.The pipeline flex was returned within phenom-27 catheter.The pushwire was found to be extending 32.0cm from hub and hypotube extending 7.2cm from distal tip.The pipeline pushwire was then removed from the phenom-27 catheter without issue.No bends or kinks were found with the pipeline flex pushwire.The pipeline flex embolization device was found be broken at distal end of hypotube.The ptfe shrink tubing was found intact on broken segment.The proximal bumper, pad and re-sheathing marker were found to be missing.The dps restraints/sleeves were found to be missing.The pipeline braid was missing and not returned.No other anomalies were observed.The broken distal hypotube was sent out for sem (scanning electron micrographic) / eds (energy dispersive spectroscopy) elemental analysis.The elemental analysis of the broken hypotube end shows tin (sn) was detected on the surface.No other anomalies were observed.Based on the device analysis and reported information, the customer¿s report of ¿pushwire break/separation¿ was confirmed.The investigation determined that this event was similar to an event that had already been investigated, regarding the pipeline flex pushwire separation issue; therefore, another investigation is not necessary.Based on the device analysis and reported information, the customer¿s report of ¿delivery system stuck during retraction¿ was unable to be confirmed and the root cause could not be determined.Possible causes of failure include, high force, pushwire damage or user does not maintain continuous flush.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PIPELINE FLEX
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 12343696
• MDR Text Key: 267309747
• Report Number: 2029214-2021-01038
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536015906
• UDI-Public: 00847536015906
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P100018.S033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/18/2024
• Device Model Number: PED-400-18
• Device Catalogue Number: PED-400-18
• Device Lot Number: B163278
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/17/2021
• Initial Date FDA Received: 08/19/2021
• Supplement Dates Manufacturer Received: 11/12/2021
• Supplement Dates FDA Received: 11/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female